International Rivaroxaban Tablet 15 mg

Adult dose

This 10 mg medicine may be taken with or without food, while the 15 mg and 20 mg doses should be taken with food. 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose is 20 mg once daily. The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) is 15 mg once daily. The maximum daily dose is 20 mg. There is limited experience with concomitant administration of rivaroxaban 15mg once daily [10mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min)] and a P2Y12 inhibitor for up to 12 months in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI) with stent placement. (See '12. Clinical Trial Information') 2) Treatment of deep vein thrombosis and pulmonary embolism / Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism The recommended initial dose for the treatment of acute deep vein thrombosis and pulmonary embolism is 15 mg twice daily for the first 3 weeks. Thereafter, the recommended maintenance dose for the treatment of deep vein thrombosis and pulmonary embolism and the recommended dose for reducing the risk of recurrence are 20 mg once daily. After completing treatment (at least 6 months) for deep vein thrombosis or pulmonary embolism, the recommended dose for extended treatment to reduce the risk of recurrence is 10mg once daily. The duration of treatment and dose should be determined following an individual assessment of the risk of recurrence of deep vein thrombosis and pulmonary embolism versus the risk of bleeding. Treatment of deep vein thrombosis or pulmonary embolism and reduction of the risk of recurrence Days 1-21: 15mg twice daily, 30mg From day 22: 20mg once daily, 20mg Reduction of the risk of recurrence of deep vein thrombosis or pulmonary embolism After at least 6 months of treatment: 10mg once daily, 10mg The maximum daily dose is 30 mg during the first 3 weeks of treatment and 20 mg thereafter. 3) Prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement) The recommended dose is 10 mg once daily. The initial dose should be administered 6~10 hours after surgery, once hemostasis has been established. The duration of treatment depends on each patient's risk of venous thromboembolism according to the type of surgery; treatment for 5 weeks is recommended for patients undergoing hip replacement and for 2 weeks for patients undergoing knee replacement. 4) If you forget to take this medicine If you forget to take this medicine, take the missed dose as follows. ① Patients taking 15 mg twice daily: Take this medicine immediately; in this case, 2 tablets of 15 mg may be taken at once. Starting the next day, continue taking 15 mg twice daily. ② Patients taking 10, 15, or 20 mg once daily: Take the missed dose immediately. Starting the next day, continue taking 1 tablet once daily. The daily dose must not be doubled to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine ① Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Discontinue vitamin K antagonist therapy and start taking this medicine when the international normalized ratio (INR, International Normalized Ratio) is ≤ 3.0. ② Treatment of deep vein thrombosis and pulmonary embolism / Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Discontinue vitamin K antagonist therapy and start taking this medicine when the INR is ≤ 2.5. Regardless of the dose, the INR value will be falsely elevated after taking this medicine. INR should not be used to measure the anticoagulant activity of this medicine, as it is not suitable for this purpose. 2) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this medicine to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Note that this medicine may affect the increase in INR. Patients switching from this medicine to a vitamin K antagonist should take the vitamin K antagonist concomitantly until the INR is ≥2.0. During the first 2 days after switching, administer the standard dose of the vitamin K antagonist; thereafter, administer the dose of the vitamin K antagonist according to INR test results. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR testing should not be performed until 24 hours after taking this medicine. Once this medicine has been discontinued, INR testing may be performed 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine In patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low molecular weight heparin), or when a continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 4) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start the parenteral anticoagulant at the time the next dose of this medicine would have been due. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50-80 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medicine increased significantly; therefore, administer this medicine with caution. There is no clinical experience in patients with severe renal impairment with creatinine clearance less than 15 mL/min; use of this medicine is not recommended. 1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation The recommended dose for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) and severe renal impairment (creatinine clearance 15-29 mL/min) is 15 mg once daily. 2) Treatment of deep vein thrombosis and pulmonary embolism / Reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism / Prevention of venous thromboembolism in adult patients undergoing major orthopedic surgery of the lower limbs (knee or hip replacement) No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 4. Patients with hepatic impairment Avoid administering this medicine to patients with liver disease associated with coagulopathy and to patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 5. Patients who cannot swallow tablets, Immediately before use, this medicine may be crushed and mixed with a beverage such as water or applesauce for oral administration. This medicine may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this medicine through a gastrointestinal tube, confirm that the tube is correctly positioned and flush the tube with water after administration.

This medication prevents or treats blood clots by inhibiting the coagulation of blood. Careful observation for signs of bleeding should be conducted as the risk of bleeding may increase with this medication. If severe bleeding occurs, the use of this medication should be stopped immediately, and a doctor should be consulted. This medication should not be used in certain patients. For instance, those who are allergic to its components, have severe bleeding, have significantly impaired liver function, are pregnant or breastfeeding, or have lactose intolerance should not take this medication. Patients with recent history of gastrointestinal ulcers or intracranial hemorrhage, vascular abnormalities, or tumors with a high risk of bleeding should also be cautious. Taking other anticoagulants or certain antifungal medications can increase the risk of bleeding, so caution is necessary. Patients with reduced kidney function or those with diseases that carry a high risk of bleeding, along with those using non-steroidal anti-inflammatory drugs or platelet inhibitors, may also have an increased risk of bleeding and should use this medication carefully. This medication may cause various side effects, the most common of which are symptoms related to bleeding. If bleeding occurs, symptoms such as paleness, dizziness, shortness of breath, or sudden swelling may be observed, so careful monitoring is needed. Additionally, rare serious side effects such as severe skin reactions or agranulocytosis have been reported, so if symptoms such as skin rashes, mucosal ulcers, or high fever occur, immediate medical attention should be sought. This medication is not administered during pregnancy due to potential risks to the fetus, and women who could become pregnant must be on contraception during treatment. Breastfeeding should also be discontinued while taking this medication. In elderly patients, renal function deterioration may cause increased blood levels of this medication; however, special dose adjustments are not usually required, although the risk of bleeding may be higher. Overdosing increases the risk of bleeding, so if an overdose occurs, medical personnel must be informed immediately, as this medication is not easily removed from the body and dialysis does not eliminate it. Symptoms such as drowsiness or fainting may appear when driving or operating machinery, so such activities should be avoided when these symptoms are present. This medication may interact with certain drugs; therefore, consultation with a medical professional is necessary if taking other medications, especially with strong CYP3A4 or P-gp inhibitors, as this can significantly increase the risk of bleeding. If surgery or invasive procedures are planned, this medication may need to be temporarily discontinued for a certain period to reduce the risk of bleeding, so consultation with a doctor is essential. While effective for the prevention and treatment of thrombosis, discontinuing treatment may increase the risk of thrombosis, so it should not be stopped arbitrarily and must be followed according to the doctor's instructions.

Hemorrhage, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, generalized decrease in strength and energy, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, discharge from wound site, vascular pseudoaneurysm, increased transaminases, elevated blood bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, elevated enzyme levels, increased bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, brain and intracranial hemorrhage, syncope, urogenital bleeding, renal dysfunction, nasal bleeding, hemoptysis, itching, rash, petechiae, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylaxis, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related kidney disease, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, melena, black stools, myocardial infarction, arthralgia, facial flushing, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, deep vein thrombosis, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is advisable to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication for a long time.

Appearance

Red, round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3), 100 tablets (10 tablets/PTP x 10)